Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Thoracoscopic Lung Resection Patients

Official title

The Effect of Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Lung Resection

Overview

This clinical trial is designed to observe the effect of dexmedetomidine nasal spray on the incidence of postoperative delirium in elderly patients undergoing thoracoscopic lung resection. Eligible elderly patients scheduled for thoracoscopic lung resection will be randomly divided into two groups: the dexmedetomidine group will receive dexmedetomidine hydrochloride nasal spray, while the placebo group will be administered an equivalent volume of placebo nasal spray. The primary outcome is the incidence of postoperative delirium within 3 days after surgery. Secondary outcomes include the severity and duration of delirium, as well as postoperative pain, subjective sleep quality, and the incidence of adverse events, which will be compared between the two groups to evaluate the safety and efficacy of dexmedetomidine nasal spray.

Interventions

• Drug Dexmedetomidine hydrochloride nasal spray
  The nasal spray group (Group D) trial medication specification is dexmedetomidine hydrochloride nasal spray at 25μg per spray. Two sprays are administered into each nostril, totalling 100μg of dexmedetomidine.
• Drug Placebo
  The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.

Primary outcome measures

• The incidence of postoperative delirium (POD) within the first 3 days after surgery [Time frame: postoperative days 1 through 3]

Secondary outcome measures (8)

• Time from End of Surgery to Tracheal Extubation (Minutes) [Time frame: From the immediate end of surgery until successful tracheal extubation, assessed up to 2 hours after surgery completion (prior to discharge from the Post-Anesthesia Care Unit [PACU]).]
• Duration of Post-Anesthesia Care Unit (PACU) Stay (Minutes) [Time frame: From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.]
• Incidence of adverse events [Time frame: From administration of the investigational product up to 7 days postoperatively.]
• Subjective sleep quality [Time frame: postoperative days 1 through 3]
• NRS pain score [Time frame: Before discharge from the PACU and on postoperative days 1 through 3.]
• The severity of postoperative delirium [Time frame: postoperative days 1 through 3]
• Duration of delirium [Time frame: Time from delirium onset to resolution, assessed up to 7 days postoperatively.]
• Duration of Postoperative Hospital Stay (Days) [Time frame: From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.]

Eligibility criteria

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status II-III.
• Age ≥ 65 years, with no gender restriction.
• Patients scheduled for elective thoracoscopic lung resection under general anesthesia, with an expected operative duration of 1-4 hours.
• Body mass index (BMI) between 18 kg/m² and 30 kg/m².

Exclusion criteria

• Known hypersensitivity to dexmedetomidine hydrochloride or any of the excipients in the investigational product.
• Pre-existing nasal conditions, nasal surgery, or nasal allergies that may significantly impair nasal drug absorption (e.g., chronic nasal congestion, rhinorrhea, epistaxis, nasal anatomical abnormalities, or mucosal pathology affecting absorption).
• History of cranial trauma.
• Pre-existing diagnosis or clinical suspicion of neurocognitive impairment, defined as a Mini-Mental State Examination (MMSE) score < 24.
• History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
• History of alcohol or substance abuse/dependence.
• Left ventricular ejection fraction < 30%; sick sinus syndrome; severe sinus bradycardia (< 50 bpm); or second- or higher-degree atrioventricular block without permanent pacemaker implantation.
• History of myocardial infarction, unstable angina, severe cardiac arrhythmia, or decompensated cardiac insufficiency.
• Asthma, emphysema, chronic bronchitis, or chronic obstructive pulmonary disease (COPD) considered inappropriate for study participation by the investigator.
• Severe hepatic impairment (Child-Pugh Class C).
• Severe renal dysfunction requiring preoperative dialysis.
• Inability to provide valid informed consent due to cultural background, language barrier, or cognitive impairment.
• Refusal to sign the informed consent form.
• Other conditions deemed inappropriate for study participation by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07579806 · SPPH2025585

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗